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Keryx Biopharmaceuticals, Inc.

Keryx Biopharmaceuticals, Inc. Recalls

All product recalls associated with Keryx Biopharmaceuticals, Inc..

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

Most Recent

Jul 2020

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–2 of 2 recalls

Auryxia Tablets (Keryx Biopharmaceuticals) – Manufacturing Deviation (2020)

cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing process for Auryxia.

Class IIModerate

FDAJul 10, 2020Nationwide• Keryx Biopharmaceuticals, Inc.

Auryxia Tablets (Keryx) – Foreign Substance Risk (2017)

Presence of Foreign Substance: Reports have been received of damaged StripPax packets containing silica gel desiccant potentially allowing the silica gel granules to make contact with Auryxia tablets in the bottle.

Class IIILow

FDADec 12, 2017Nationwide• Keryx Biopharmaceuticals, Inc.